附件 2、歷年廢除或改版之醫療器材標準清單

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1. 本清單所列醫療器材標準，為本署過去曾公告採認，然因該項標準已被廢除或改版者，詳見備註說明欄。

2. 提供 104 年至 110 年廢除或改版之醫療器材標準共 1,154 項如下表。

序號標準類別 TFDA 採認編

號

標準組

織名稱標準號碼標準

版本標準名稱備註說明

1 Anesthesias 麻醉學

TFDA-00093 IEC IEC 60601-3-1:1996 1996 Medical Electrical Equipment Part 3-1: Essential

Performance Requirements for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment

本標準已廢除，無取代標準。

TFDA-00094 ISO ISO 5360:1993 1998 Anaesthetic vaporizers - Agent specific filling systems 本標準已改版，請參考新版本標準。(ISO 5360:2016) 3 Anesthesias 麻醉

學

TFDA-00095 ISO ISO 5361:1999 1999 Anaesthetic and Respiratory Equipment - Tracheal Tubes and Connectors

本標準已改版，請參考新版本標準。(ISO 5361:2016) 4 Anesthesias 麻醉

學

TFDA-00096 ISO ISO 5361-4:1987 1987 Tracheal Tubes - Part 4: Cole Type 本標準已改版，請參考新版本標準。(ISO 5361:2016) 5 Anesthesias 麻醉

學

TFDA-00097 ISO ISO 5362:2000 2000 Anaesthetic Reservoir Bags 本標準已改版，請參考新版

本標準。(ISO 5362:2006) 6 Anesthesias 麻醉

學

TFDA-00098 ISO ISO 5366-1:2000 2000 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults

學

TFDA-00099 ISO ISO 5366-3:2001 2003 Anaesthetic and Respiratory Equipment -- Tracheostomy Tubes -- Part 3: Pediatric Tracheostomy Tubes

本標準已改版，請參考新版本標準。(ISO 5366:2016 ) 8 Anesthesias 麻醉

學

TFDA-00100 ISO ISO 5367:2000 2000 Breathing Tubes intended for use with Anaesthetic Apparatus and Ventilators

本標準已改版，請參考新版本標準。(ISO 5367:2014)

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2/158

學 Requirements 本標準。(ISO 8359:1996/Amd

1:2012) 11 Anesthesias 麻醉

學

TFDA-00103 ISO ISO 8382:1988 1988 Resuscitators Intended for Use with Humans 本標準已廢除，請參考新標準。(ISO 10651-5: 2006) 12 Anesthesias 麻醉

學

TFDA-00104 ISO ISO 9918:1993 1993 Capnometers for Use with Humans - Requirements 本標準已廢除，請參考新標準。(ISO 80601-2-55:2011) 13 Anesthesias 麻醉

學

TFDA-00262 ASTM ASTM F1850-00 2000 Standard Specification for Particular Requirements for Anesthesia Workstations and Their Components1

本標準已改版，請參考新版本標準。(ASTM

F1850-00/(R)2005) 14 Anesthesias 麻醉

學

TFDA-00265 ASTM ASTM

F920-93(R1999)

1993 Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans

本標準已廢除，請參考新標準。(ISO 10651-4: 2002)

F1100-90(R1997)

1990 Standard Specification for Ventilators Intended for Use in Critical Care

本標準已廢除，請參考新版本標準。(ISO

80601-2-12:2011/Cor 1:2011) 16 Anesthesias 麻醉

學

F1101-90(R2003)e1

2003 Standard Specification for Ventilators Intended for Use During Anesthesia

本標準已廢除，請參考新標準。(ISO

80601-2-12:2011/Cor 1:2011) 17 Anesthesias 麻醉

學

TFDA-00270 ASTM ASTM G175-03 2003 Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications

本標準已改版，請參考新版本標準。(ASTM G175-13)

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3/158

學 Pressure regulators and pressure regulators with

flow-metering devices

本標準。(ISO 10524-1: 2018)

TFDA-00406 ISO ISO 10524-2: 2005 2005 Pressure regulators for use with medical gases – Part 2:

Manifold and line pressure regulators

本標準已改版，請參考新版本標準。(ISO 10524-2: 2018) 21 Anesthesias 麻醉

學

TFDA-00407 ISO ISO 10524-3: 2005 2005 Pressure regulators for use with medical gases – Part 3:

Pressure regulators integrated with cylinder valves

本標準已改版，請參考新版本標準。(ISO

10524-3:2005/Amd 1:2013) 22 Anesthesias 麻醉

學

TFDA-00408 ISO ISO 10651-3:1997 1997 Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services

environment

本標準已被廢除，請參考新標準。(ISO 80601-2-84:2020)

TFDA-00411 ISO ISO 21647: 2004/Cor 1:2005

2005 Medical electrical equipment – Particular requirements for the basic safety and essential performance of respiratory gas monitors-Technical Corrigendum 1

本標準已廢除，請參考新標準。(ISO 80601-2-55:2011)

TFDA-00445 ISO ISO 18779:2005 2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements

本標準已被廢除，請參考新標準。(ISO

80601-2-67:2014) 25 Anesthesias 麻醉

學

TFDA-00572 CNS CNS 15003-1 2006 醫療氣體管線系統－第１部：壓縮醫療氣體及真空用管

線

原採認標準已廢除

TFDA-00573 CNS CNS 15003-2 2006 醫療氣體管線系統－第２部：麻醉氣體之清理排放系統原採認標準已廢除

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4/158

學系統之終端單元

TFDA-00694 ISO ISO 5360:2006 2006 Anaesthetic vaporizers -- Agent-specific filling systems 本標準已改版，請參考新版本標準。(ISO 5360:2016) 30 Anesthesias 麻醉

學

F1850-00/(R)2005

2005 Standard Specification for Particular Requirements for Anesthesia Workstations and Their Components

TFDA-01154 ASTM ASTM G175 - 03(R2011)

2011 ASTM G175 - 03(2011) Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications

本標準已改版，請參考新版本標準。(ASTM G175-13)

TFDA-01159 EN EN

13544-1:2007+A1:20 09

2010 Respiratory therapy equipment - Part 1: Nebulizing systems and their components - Incorporates Amendment A1: 2009

原採認標準已廢除，請參考取代標準。(EN ISO 27427 : 2019)

TFDA-01160 IEC IEC 60601-2-13:2009 2009 Medical electrical equipment – Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems - Edition 3.1; Consolidated Reprint

本標準已被廢除，請參考新標準。(ISO 80601-2-13:2011 + AMD 1:2015)

TFDA-01161 IEC IEC 60601-2-49:2011 2011 Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment - Edition 2.0

本標準已改版，請參考新版本標準。(IEC

80601-2-49:2018) 35 Anesthesias 麻醉

學

TFDA-01162 ISO ISO 10079-1:1999 1999 Medical suction equipment Part 1: Electrically powered suction equipment - Safety requirements

本標準已改版，請參考新版本標準。(ISO 10079-1:2015) 36 Anesthesias 麻醉 TFDA-01163 ISO ISO 10079-2:1999 1999 Medical suction equipment - Part 2: Manually powered 本標準已改版，請參考新版

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5/158 38 Anesthesias 麻醉

學

TFDA-01166 ISO ISO 14408:2005 2005 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information

學

TFDA-01169 ISO ISO 23747:2007 2007 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

TFDA-01171 ISO ISO 5360:2012 2012 Anaesthetic vaporizers -- Agent-specific filling systems 本標準已改版，請參考新版本標準。(ISO 5360:2016) 41 Anesthesias 麻醉

學

TFDA-01172 ISO ISO 5361:2012 2012 Anaesthetic and respiratory equipment -- Tracheal tubes and connectors

學

TFDA-01174 ISO ISO 80601-2-12:2011 2011 Medical electrical equipment -- Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators

80601-2-12:2020) 43 Anesthesias 麻醉

學

TFDA-01175 ISO ISO

80601-2-12:2011/Cor 1:2011

2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators TECHNICAL CORRIGENDUM 1 - First Edition

80601-2-12:2020)

TFDA-01176 ISO ISO 80601-2-55:2011 2011 Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

80601-2-55:2018) 45 Anesthesias 麻醉

學

TFDA-01177 ISO ISO 8359:1996/Amd 1:2012

2012 Oxygen Concentrators for Medical Use - Safety Requirements

本標準已被廢除，請參考新標準。(ISO 80601-2-69:2014)

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6/158 47 Anesthesias 麻醉

學

TFDA-01458 ISO ISO 5359:2014 2014 Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases

5359:2014+A1:2107) 48 Anesthesias 麻醉

學

TFDA-01464 ISO ISO 7376:2009 2009 Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation

學

TFDA-01465 ISO ISO 80369-7:2016 2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications

本標準已改版，請參考新版本標準。(ISO 80369-7:2021)

TFDA-01466 ISO ISO

80601-2-13:2011/Am d1:2015

2015 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

80601-2-13:2018) 51 Anesthesias 麻醉

學

TFDA-01467 ISO ISO 80601-2-67:2014 2014 Medical electrical equipment — Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

80601-2-67:2020) 52 Anesthesias 麻醉

學

TFDA-01468 ISO ISO 80601-2-69:2014 2014 Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

80601-2-69:2020) 53 Anesthesias 麻醉

學

TFDA-01469 ISO ISO 8836:2014 2014 Suction catheters for use in the respiratory tract 本標準已改版，請參考新版本標準。(ISO 8836:2019) 54 Anesthesias 麻醉

學

TFDA-01764 IEC IEC 80601-2-13:2018 2018 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of

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學 - Part 2: Screw-threaded weight-bearing connectors 本標準。(ISO

5356-2:2012/AMD 1:2019) 56 Anesthesias 麻醉

學

TFDA-01772 ISO ISO 80601-2-70:2015 2015 Medical electrical equipment — Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

80601-2-70:2020) 57 Biocompatibility

生物相容性

TFDA-00006 ISO ISO 10993-1：2003 2003 Biological evaluation of medical devices -- Part 1:

Evaluation and testing.

10993-1:2009/Cor1:2010) 58 Biocompatibility

生物相容性

TFDA-00007 ISO ISO 10993-10：2002 2002 Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization -- Maximization sensitization test.

10993-10:2010 ) 59 Biocompatibility

生物相容性

TFDA-00008 ISO ISO 10993-11：1993 1993 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.

本標準已改版，請參考新版本標準。(ISO 10993-11:2006) 60 Biocompatibility

生物相容性

TFDA-00009 ISO ISO 10993-12：2002 2002 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials.

生物相容性

TFDA-00010 ISO ISO 10993-5：1999 1999 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.

本標準已改版，請參考新版本標準。(ISO 10993-5:2009 ) 62 Biocompatibility

生物相容性

TFDA-00011 ISO ISO 10993-6：1994 1994 Biological evaluation of medical devices -- Part 6: Test for local effects after implantation.

生物相容性

TFDA-00012 ISO ISO 10993-7：1995 1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals.

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8/158 65 Biocompatibility

生物相容性

TFDA-00018 ISO ISO 10993-4:2002 2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood

10993-4:2002/Amd 1:2006) 66 Biocompatibility

生物相容性

TFDA-00019 ISO ISO 10993-9:1999 1999 Biological evaluation of medical devices -- Part 9:

Framework for identification and quantification of potential degradation products

67 Biocompatibility 生物相容性

Identification and quantification of degradation products from polymeric

生物相容性

Identification and quantification of degradation products from metals an

Toxicokinetic study design for degradation products and leachables

生物相容性

TFDA-00346 ISO ISO 10993-18:2005 2005 Biological evaluation of medical devices —Part 18:

Chemical characterization of materials

生物相容性

TFDA-00347 ISO ISO/TS 10993-19:2006

2006 Biological evaluation of medical devices —Part 19:

Physico-chemical, morphological and topographical characterization of materials

本標準已改版，請參考新版本標準。(ISO/TS

10993-19:2020)

72 Biocompatibility TFDA-00514 ISO ISO 10993-3:2003 2003 Biological evaluation of medical devices -- Part 3: Tests for 本標準已改版，請參考新版

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9/158 1:2006

TFDA-00516 ISO ISO 10993-6:2007 2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation

生物相容性

TFDA-00517 ISO ISO

10993-10:2002/Amd 1:2006

2006 Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity

生物相容性

TFDA-00518 ISO ISO 10993-11:2006 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity

生物相容性

TFDA-00533 ISO ISO/TS 20993:2006 2006 Biological evaluation of medical devices -- Guidance on a risk-management process

本標準已廢除，請參考新標準。(ISO

10993-1:2009/Cor1:2010) 78 Biocompatibility

生物相容性

TFDA-00668 ISO ISO 10993-12:2007 2008 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

生物相容性

TFDA-00726 ISO ISO 10993-7：2008 2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

10993-7:2008/Cor 1:2009) 80 Biocompatibility

生物相容性

Framework for identification and quantification of potential degradation products

Toxicokinetic study design for degradation products and

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10/158 83 Biocompatibility

生物相容性

TFDA-01020 ASTM ASTM F720-13 2013 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

本標準已改版，請參考新版本標準。(ASTM F720:2017) 84 Biocompatibility

生物相容性

TFDA-01021 ASTM ASTM F749-13 2013 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

本標準已改版，請參考新版本標準。(ASTM F749 - 20) 85 Biocompatibility

生物相容性

F750-87/(R)2012

2012 Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse

生物相容性

TFDA-01023 ASTM F813 - 07(2012) 2012 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

生物相容性

TFDA-01024 ISO ISO 10993-12:2012 2012 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

生物相容性

TFDA-01025 ISO ISO

10993-7:2008/Cor 1:2009

2009 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

10993-7:2008/Amd 1:2019) 89 Biocompatibility

生物相容性

F2382-04/(R)2010

2010 Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)

本標準已改版，請參考新版本標準。(ASTM F2382-17)

TFDA-01774 ASTM ASTM F2382-17 2017 Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)

本標準已改版，請參考新版本標準。(ASTM F2382 - 18)

91 Cardiovascular 心臟血管醫學

TFDA-00313 IEC IEC 60601-2-31:1994 1998 Medical electrical equipment, Part 2: Particular requirements for the safety of external cardiac pacemakers with internal

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11/158

心臟血管醫學 Requirements for the Safety of Electrocardiographs 本標準。(IEC

60601-2-25:2011) 93 Cardiovascular

心臟血管醫學

TFDA-00316 IEC IEC 60601-2-47 2001 Medical Electrical Equipment Part 2-47: Particular Requirements for the Safety, including Essential

Performance of Ambulatory Electrocardiographic Systems

60601-2-47:2012 ed2.0) 94 Cardiovascular

心臟血管醫學

TFDA-00317 IEC IEC 60601-2-4 2002 Particular Requirements for the Safety of Cardiac Defibrillator

本標準已改版，請參考新版本標準。(IEC 60601-2-4:2010 ed3.0)

TFDA-00446 ISO ISO 5840:2005 2005 Cardiovascular implants - Cardiac valve prostheses 本標準已改版，請參考新版本標準。(ISO 5840-1:2015) 96 Cardiovascular

心臟血管醫學

TFDA-00447 ISO ISO 14708-2: 2005 2005 Implants for surgery – Active implantable medical devices – Part 2: Cardiac pacemakers

本標準已改版，請參考新版本標準。(ISO 14708-2:2012) 97 Cardiovascular

心臟血管醫學

TFDA-00448 ISO ISO

25539-1:2003/Amd 1:2005

2005 Cardiovascular implants – Endovascular devices – Part 1:

Endovascular prostheses – Amendment 1: Test methods

TFDA-00449 ISO ISO 15676:2005 2005 Cardiovascular implants and artificial organs – Requirements for single-use tubing packs for

cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)

15676:2016membrane oxygenation (ECMO) - Second Edition)

99 Cardiovascular TFDA-00450 ISO ISO 7198:1998 1998 Cardiovascular implants — Tubular vascular prostheses 本標準已改版，請參考新版

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12/158 101 Cardiovascular

心臟血管醫學

TFDA-00454 ISO ISO 15674:2001 2001 Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

TFDA-00455 ISO ISO 15675:2001 2001 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial line blood filters

TFDA-00456 ISO ISO 13960:2003 2003 Cardiovascular implants and artificial organs – Plasmafilters

本標準已改版，請參考新版本標準。(ISO 13960:2010 ) 104 Cardiovascular

心臟血管醫學

TFDA-00474 CEN EN 14299:2004 2004 Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents

本標準已廢除，請參考新標準。(ISO 25539-1:2017)

TFDA-00475 CEN EN 12006-1:1999 1999 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes

本標準已廢除，請參考新標準。(ISO 5840-1:2015)

TFDA-00476 CEN EN 12006-2:1998 1998 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

本標準已改版，請參考新版本標準。(EN

12006-2:1998+A1:2009) 107 Cardiovascular

心臟血管醫學

TFDA-00477 CEN EN 12006-3:1998 1999 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

本標準已廢除，請參考新標準。(ISO 25539-1:2017) 108 Cardiovascular

心臟血管醫學

TFDA-00605 ASTM ASTM F2081-01 2001 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

本標準已改版，請參考新版本標準。

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(including automated external defibrillators) ed3.0) 110 Cardiovascular

心臟血管醫學

TFDA-00614 AAMI AAMI

EC11:1991(R2001)

2001 Diagnostic electrocardiographic devices 本標準已廢除，請參考新標準。(IEC 60601-2-25:2011) 111 Cardiovascular

心臟血管醫學

EC12:2000/(R)2005

2005 Disposable ECG electrodes 本標準已改版，請參考新版

本標準。(AAMI EC12:2000/(R)2010 ) 112 Cardiovascular

心臟血管醫學

EC53:1995/(R)2001

2001 ECG cables and leadwires 本標準已改版，請參考新版

本標準。(AAMI EC53:2013) 113 Cardiovascular

心臟血管醫學

EC57:1998/(R)2003

2003 Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms

本標準已改版，請參考新版本標準。(AAMI EC57:2012) 114 Cardiovascular

心臟血管醫學

TFDA-00619 IEC IEC 60601-2-27:1994 1994 Medical electrical equipment- Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment

心臟血管醫學

TFDA-00620 IEC IEC 60601-2-30:1999 1999 Medical electrical equipment- Part 2-30: Particular

requirements for safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment

本標準已廢除，請參考新標準。(IEC 80601-2-30:2013)

TFDA-00621 IEC IEC 60601-2-34:2000 2000 Medical electrical equipment –Part 2-34: Particular

requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment

60601-2-34:2011 ed3.0) 117 Cardiovascular TFDA-00625 ISO ISO 5841-1:1989 1989 Cardiac Pacemakers - Part 1 : Implantable Pacemakers 本標準已廢除，請參考新標

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generators or leads 119 Cardiovascular

心臟血管醫學

TFDA-00627 ISO ISO 5841-3:2000 2000 Implants for surgery — Cardiac pacemakers — Part 3:

Low-profile connectors [IS-1] for implantable pacemakers

心臟血管醫學

SP10:2002/A1:2003

2002 Manual, electronic, or automated sphygmomanometers 本標準已廢除，請參考新標準。(ISO 81060-1:2007) 121 Cardiovascular

心臟血管醫學

TFDA-00704 AAMI EC11:1991/(R)2007 1991 Diagnostic electrocardiographic devices 本標準已廢除，請參考新標準。(IEC 60601-2-25:2011) 122 Cardiovascular

心臟血管醫學

TFDA-00705 ASTM F2081-06 2009 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

本標準已改版，請參考新版本標準。

(ASTM F2081-06/(R)2013) 123 Cardiovascular

心臟血管醫學

TFDA-00706 IEC IEC 60601-2-27 Edition 2.0 (2005-08)

2005 Medical electrical equipment - Part 2-27: Particular

requirements for the safety, including essential performance, of electrocardiographic monitoring equipment

心臟血管醫學

TFDA-00707 IEC IEC 60601-2-31 Edition 2.0 (2008-03)

2008 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

60601-2-31:2011 ed2.1 Consol. with am1) 125 Cardiovascular

心臟血管醫學

TFDA-00779 ISO ISO 9919:2005 2005 Medical electrical equipment -- Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

本標準已廢除，請參考新標準。(ISO 80601-2-61:2011)

126 Cardiovascular TFDA-00904 ISO ISO 7199:2009 2009 Cardiovascular implants and artificial organs -- Blood-gas 本標準已改版，請參考新版

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and soft venous reservoir bags 128 Cardiovascular

心臟血管醫學

TFDA-00906 ISO ISO 15675:2009 2009 Cardiovascular implants and artificial organs -- Cardiopulmonary bypass systems -- Arterial blood line filters

TFDA-00908 AAMI EC53:1995/(R)2008 2008 ECG cables and leadwires 本標準已改版，請參考新版本標準。(AAMI EC53:2013) 130 Cardiovascular

心臟血管醫學

TFDA-00909 AAMI EC57:1998/(R)2008 2008 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms

本標準已改版，請參考新版本標準。(AAMI EC57:2012) 131 Cardiovascular

心臟血管醫學

TFDA-00910 ISO ANSI/AAMI/ISO 81060-2:2009

2009 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type

心臟血管醫學

TFDA-00976 CEN EN 1060-1:1995 1995 Specification for Non-invasive sphygmomanometers Part 1.

General requirements

本標準已廢除，請參考新標準。(ISO 81060-1:2007) 133 Cardiovascular

心臟血管醫學

TFDA-00977 CEN EN 1060-3:1997 1997 Non-invasive sphygmomanometers Part 3. Supplementary requirements for electro-mechanical blood pressure measuring systems

本標準已改版，請參考新版本標準。(EN

1060-3:1997+A2:2009) 134 Cardiovascular

心臟血管醫學

EC12:2000/(R)2010

本標準。(AMMI EC12:2000/(R2015)) 135 Cardiovascular

心臟血管醫學

TFDA-01179 AAMI AAMI EC53:2013 2013 ECG trunk cables and patient leadwires 本標準已改版，請參考新版本標準。(AAMI

EC53:2013(R2020))

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心臟血管醫學

TFDA-01182 AAMI AAMI/ISO 14117:2012

2012 Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices.

本標準已改版，請參考新版本標準。(AAMI/ISO 14117:2019)

TFDA-01183 AAMI IEC 60601-2-25:2011 2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.

60601-2-25:2011(R2016)) 139 Cardiovascular

心臟血管醫學

TFDA-01184 ASTM ASTM F2081-06/(R) 2013

2013 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

本標準已改版，請參考新版本標準。(ASTM F2081 - 06(2017))

TFDA-01185 ASTM ASTM F138- 00 2000 Standard Specification for Wrought 18 Chromium 14 Nickel 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F1984-99/(R)2008

2008 Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

TFDA-01187 ASTM ASTM F2004 - 05(R2010)

2010 Standard Test Method for Transformation Temperature of Nickel Titanium Alloys by Thermal Analysis

本標準已改版，請參考新版本標準。(ASTM F2004-16) 143 Cardiovascular

心臟血管醫學

F2065-00e1/(R)2010

2010 Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials

144 Cardiovascular TFDA-01189 ASTM ASTM F2079-09 2009 Standard Test Method for Measuring Intrinsic Elastic Recoil 本標準已改版，請參考新版

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心臟血管醫學 Temperature of Nickel Titanium Shape Memory Alloys by

Bend and Free Recovery

本標準。(ASTM F2082/F2082M-16) 146 Cardiovascular

心臟血管醫學

TFDA-01191 ASTM ASTM F2129 - 08 2008 Standard Test Method for Conducting Cyclic

Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

TFDA-01192 ASTM ASTM F2394-07 2007 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

F746-04/(R)2009e1

2009 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

G71-81/(R)2009

2009 Standard Guide for Conducting and Evaluating Galvanic Corrosion Tests in Electrolytes

本標準已改版，請參考新版本標準。(ASTM G71 - 81(2019))

TFDA-01195 CEN EN

1060-3:1997+A2:200 9

2009 Non-invasive sphygmomanometers. Supplementary requirements for electro-mechanical blood pressure measuring systems

TFDA-01196 CEN EN

12006-2:1998+A1:20 09

2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2:Vascular prostheses including cardiac valve conduits

本標準已被廢除，請參考新標準。(ISO 7198:2017)

152 Cardiovascular TFDA-01197 CEN EN ISO 5840:2009 2009 Cardiovascular implants - Cardiac valve prostheses 本標準已改版，請參考新版

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requirements for the safety of multifunction patient monitoring equipment (IDT: IEC 61267:2005) 154 Cardiovascular

心臟血管醫學

TFDA-01201 IEC IEC 60601-2-27:2011 ed3.0

2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

心臟血管醫學

TFDA-01202 IEC IEC 60601-2-31:2011 ed2.1 Consol. with am1

2011 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

60601-2-31:2020 ) 156 Cardiovascular

心臟血管醫學

TFDA-01204 IEC IEC 60601-2-4:2010 ed3.0

2010 Medical electrical equipment - Part 2-4: Particular

requirements for the basic safety and essential performance of cardiac defibrillators

心臟血管醫學

TFDA-01206 IEC IEC 80601-2-30:2013 2013 Medical electrical equipment – Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers - Edition 1.1

80601-2-30:2018)

TFDA-01207 IEC IEC 80601-2-61:2012 2011 Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment - Edition 1.0

本標準已改版，請參考新版本標準。(ISO/IEC

心臟血管醫學

TFDA-01209 ISO ISO 14708-2:2012 2012 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers

本標準已改版，請參考新版本標準。(ISO 14708-2:2019) 160 Cardiovascular TFDA-01212 ISO ISO 25539-1:2009 2009 Cardiovascular implants - Endovascular devices - Part 1: 本標準已改版，請參考新版

(19)

心臟血管醫學

TFDA-01216 ISO ISO 7199:2009/Amd 1:2012

2012 Clarifications for test methodologies, labelling, and sampling schedule

本標準已改版，請參考新版本標準。(ISO 7199:2016) 163 Cardiovascular

心臟血管醫學

TFDA-01217 ISO ISO 80601-2-61:2011 2011 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

心臟血管醫學

TFDA-01221 OIML OIML D11:2004 2004 General requirements for electronic measuring instruments 本標準已改版，請參考新版本標準。(OIML D11 (2013)) 165 Cardiovascular

心臟血管醫學

TFDA-01476 ASTM ASTM F138-13 2013 Standard Specification for Wrought 18 Chromium 14 Nickel 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

本標準已改版，請參考新版本標準。(ASTM F138 - 19)

TFDA-01477 ASTM ASTM F2004-16 2016 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

本標準已改版，請參考新版本標準。(ASTM F2004-17) 167 Cardiovascular

心臟血管醫學

TFDA-01479 ASTM ASTM F2129-15 2015 Standard Test Method for Conducting Cyclic

Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

TFDA-01480 ASTM ASTM F2942-13 2013 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

本標準已改版，請參考新版本標準。(ASTM F2942 - 19) 169 Cardiovascular

心臟血管醫學

TFDA-01483 ISO ISO 15674:2016 2016 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

15674:2016/AMD 1:2020) 170 Cardiovascular TFDA-01484 ISO ISO 15675:2016 2016 Cardiovascular implants and artificial organs - 本標準已改版，請參考新版

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20/158

心臟血管醫學 1: General requirements 本標準。(ISO 5840-1:2021)

TFDA-01488 ISO ISO 5840-2:2015 2015 Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes

心臟血管醫學

TFDA-01489 ISO ISO 5840-3:2013 2013 Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques

TFDA-01491 ISO ISO 7199:2016 2016 Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)

7199:2016/AMD 1:2020) 175 Cardiovascular

心臟血管醫學

TFDA-01493 ISO ISO/TS 17137:2014 2014 Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants

本標準已改版，請參考新版本標準。(ISO/TS 17137:2019) 176 Cardiovascular

心臟血管醫學

EC12:2000/(R2015)

本標準。(ANSI/AAMI EC12:2000 (R2020)) 177 Cardiovascular

心臟血管醫學

TFDA-01882 ASTM ASTM F746 - 04(2014)

2014 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

178 Dental/ENT 牙科學/耳鼻喉科學

TFDA-00057 ISO ISO 13294:1997 1997 Dental Handpieces - Dental Air-Motors 本標準已廢除，請參考新標準。(ISO 14457:2012) 179 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00058 ISO ISO 3336:1993 1993 Dentistry - Synthetic Polymer Teeth 本標準已改版，請參考新版本標準。(ISO 22112:2005 )

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21/158

學/耳鼻喉科學準。(ISO 7494-1:2011)

TFDA-00061 ISO ISO 7494-2:2003 2003 Dentistry - Dental units - Part 2: Water and air supply 本標準已改版，請參考新版本標準。(ISO 7494-2:2015) 183 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00062 ISO ISO 7785-1:1997 1997 Part 1: High-Speed Air Turbine Handpieces 本標準已廢除，請參考新標準。(ISO 14457:2012) 184 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00063 ISO ISO 7785-2:1995 1995 Part 2: Straight and Geared Angle Handpieces 本標準已廢除，請參考新標準。(ISO 14457:2012) 185 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00064 ISO ISO 9168:1991 1991 Dental Handpieces - Hose Connectors 本標準已改版，請參考新版本標準。(ISO 9168:2009 ) 186 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00240 ISO ISO 1562:1993 1993 Dental Casting Gold Alloys 本標準已廢除，請參考新標

準。(ISO 22674:2016) 187 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00241 ISO ISO 1563:1990 1990 Dental Alginate Impression Material 本標準已廢除，請參考新標準。(ISO 21563:2013) 188 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00242 ISO ISO 1564:1995 1995 Dental Aqueous Impression Materials Based on Agar 本標準已廢除，請參考新標準。(ISO 21563:2013) 189 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00243 ISO ISO 3107:1988 1988 Dental Zinc Oxide/Eugenol Cements and Zinc Oxide Non-Eugenol Cements

本標準已改版，請參考新版本標準。(ISO 3107:2011) 190 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00244 ISO ISO 6871-1:1994 1994 Dental base metal casting alloys Part 1: Cobalt-based alloys - TECHNICAL CORRIGENDUM 1:1998

本標準已廢除，請參考新標準。(ISO 22674:2016) 191 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00245 ISO ISO 6871-2:1994 1994 Dental Base Metal Casting Alloys Part 2: Nickel-Based Alloys

本標準已廢除，請參考新標準。(ISO 22674:2016)

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22/158

學/耳鼻喉科學本標準。(ISO 6874:2015)

TFDA-00248 ISO ISO 6876:2001 2001 Dental Root Canal Sealing Materials 本標準已改版，請參考新版本標準。(ISO 6876:2012) 195 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00249 ISO ISO 6877:1995 1995 Dental Root-Canal Obturating Points 本標準已改版，請參考新版本標準。(ISO 6877:2006) 196 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00250 ISO ISO 10477:1996 2001 Dentistry - Polymer-Based Crown and Bridge Materials 本標準已改版，請參考新版本標準。(ISO 10477:2004) 197 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00251 ISO ISO 11498:1997 1997 Dental Handpieces: Dental Low Voltage Electrical Motors 本標準已廢除，請參考新標準。(ISO 14457:2012) 198 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00252 ISO ISO 13294:1997 1997 Dental Handpieces - Dental Air-Motors 本標準已廢除，請參考新標準。(ISO 14457:2012) 199 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00253 ISO ISO 8891:2000 1998 Dental Casting Alloys with Noble Metal Content of At Least 25% but less than 75%

學/耳鼻喉科學

TFDA-00254 ISO ISO 9693:1999 1999 Metal-Ceramic Dental Restorative Systems 本標準已改版，請參考新版本標準。(ISO 9693-1:2012) 201 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00255 ISO ISO 9917-2:1998 1998 Dental Water-Based Cements - Part 2: Light-Activated Cements

本標準已改版，請參考新版本標準。(ISO 9917-2:2010) 202 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00256 ISO ISO 13716:1999 1999 Dentistry - Reversible-Irreversible Hydrocolloid Impression Material Systems

學/耳鼻喉科學

TFDA-00257 ISO ISO 9917-1:2003 2002 Dental Water-Based Cements - Part 1: Powder/Liquid Acid-Base Cements - First Edition

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23/158

1:2006) 205 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00259 ISO ISO 10139-2:1999 1999 Dentistry - Resilient lining materials for removable dentures - Part 2: Materials for long-term use

學/耳鼻喉科學

TFDA-00260 ISO ISO 7494-1:2004 2004 Dentistry - Dental units - Part 1: General requirements and test methods

學/耳鼻喉科學

TFDA-00374 ANSI ADA Specification No.96

2000 Dental-Water-Based Cements - Adoption of ISO 9917:1991 本標準已改版，請參考新版本標準。(ADA 96-2012 ) 208 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00375 CEN EN 1639:1996 1996 Dentistry - Medical devices for dentistry - Instruments 本標準已改版，請參考新版本標準。(EN 1639:2009) 209 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00376 CEN EN 1640:1996 1996 Dentistry - Medical devices for dentistry - Equipment 本標準已改版，請參考新版本標準。(EN 1640:2009) 210 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00377 CEN EN 1641:1996 1996 Dentistry - Medical devices for dentistry - Materials 本標準已改版，請參考新版本標準。(EN 1641:2009) 211 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00378 CEN EN 1642:1996 1996 Dentistry - Medical devices for dentistry - Dental implants 本標準已改版，請參考新版本標準。(EN 1642:2011) 212 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00379 ISO ISO 6360-1: 2004 2004 Dentistry -- Number coding system for rotary instruments -- Part 1: General characteristics

本標準已改版，請參考新版本標準。(ISO 6360-1 CORR 1:2007)

TFDA-00380 ISO ISO 6360-2: 2004 2004 Dentistry -- Number coding system for rotary instruments -- Part 2: Shapes

6360-2:2004/Amd 1:2011)

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24/158 215 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00389 ISO ISO 15854:2005 2005 Dentistry – Casting and baseplate waxes 本標準已改版，請參考新版本標準。(ISO 15854:2021) 216 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00390 ANSI ASA S3.6-2004 2004 Specification for Audiometers 本標準已改版，請參考新版本標準。(ASA S3.6 (2010) ) 217 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00391 ANSI ASA S3.22:2003 2003 Specification of Hearing Aid Characteristics 本標準已改版，請參考新版本標準。(ASA S3.22 (2014)) 218 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00392 ISO ISO 7405:1997 1997 Dentistry -- Preclinical evaluation of biocompatibility of medical devices used in dentistry -- Test methods for dental materials

本標準已改版，請參考新版本標準。(ISO 7405:2008/Amd 1:2013)

TFDA-00393 ISO ISO 3107:2004 2006 Dentistry -- Zinc oxide/eugenol and zinc oxide/non-eugenol cements

學/耳鼻喉科學

TFDA-00680 CEN EN 1639:2004 2004 Dentistry - Medical devices for dentistry - Instruments 本標準已改版，請參考新版本標準。(EN 1639:2009) 221 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00681 CEN EN 1640:2004 2004 Dentistry - Medical devices for dentistry - Equipment 本標準已改版，請參考新版本標準。(EN 1640:2009) 222 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00682 CEN EN 1641:2004 2004 Dentistry - Medical devices for dentistry - Materials 本標準已改版，請參考新版本標準。(EN 1641:2009) 223 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00683 CEN EN 1642:2004 2004 Dentistry - Medical devices for dentistry - Dental implants 本標準已改版，請參考新版本標準。(EN 1642:2011) 224 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00684 ISO ISO 10139-1:2005 &

ISO

2006 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use Technical Corrigendum

本標準已改版，請參考新版本標準。(ISO 10139-1: 2018)

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25/158

學/耳鼻喉科學本標準。(ISO 10477:2018)

TFDA-00686 ISO ISO 6874:2005 2005 Dentistry -- Polymer-based pit and fissure sealants 本標準已改版，請參考新版本標準。(ISO 6874:2015) 227 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00688 ISO ISO 22674:2006 2006 Dentistry -- Metallic materials for fixed and removable restorations and appliances

學/耳鼻喉科學

TFDA-00689 ISO ISO 9693:1999/Amd 1:2005

2005 Metal-ceramic dental restorative systems. 本標準已被廢除，請參考新標準。(ISO 9693-1:2012) 229 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00871 ISO ISO 22112:2005 2005 Dentistry -- Artificial teeth for dental prostheses 本標準已改版，請參考新版本標準。(ISO 22112:2107) 230 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00872 ISO ISO 4049:2009 2009 Dentistry -- Polymer-based restorative materials 本標準已改版，請參考新版本標準。(ISO 4049:2019) 231 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00874 ISO ISO 6872:2008 2008 Dentistry -- Ceramic materials 本標準已改版，請參考新版本標準。(ISO 6872:2015) 232 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-00875 ISO ISO 9917-2:2010 2010 Dentistry -- Water-based cements -- Part 2: Resin-modified cements

學/耳鼻喉科學

TFDA-00876 ISO ISO 10139-2:2009 2009 Dentistry -- Soft lining materials for removable dentures -- Part 2: Materials for long-term use

學/耳鼻喉科學

TFDA-00877 ISO ISO 7405:2008 2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry

本標準已改版，請參考新版本標準。(ISO 7405:2008/Amd 1:2013)

235 Dental/ENT 牙科 TFDA-00879 ASA ANSI/ASA 2009 Specification of Hearing Aid Characteristics 本標準已改版，請參考新版

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26/158

polymeric aterials) 237 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-01228 CNS CNS 15492 2012 牙膏與牙粉 Toothpastes (Dentifrices) 本標準適用範圍(牙膏與牙

粉)不屬於我國醫療器材管理範圍。

TFDA-01230 ISO ISO 14457:2012 2012 Dentistry -- Handpieces and motors 本標準已改版，請參考新版本標準。(ISO 14457:2017) 239 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-01231 ISO ISO 14801:2007 2007 Dentistry — Implants — Dynamic fatigue test for endosseous dental implants - Second Edition

學/耳鼻喉科學

TFDA-01237 ISO ISO 7494-1:2011 2011 Dentistry -- Dental units -- Part 1: General requirements and test methods

學/耳鼻喉科學

TFDA-01239 IEC IEC 80601-2-60:2012 ed1.0

2012 Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

80601-2-60:2019 ) 242 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-01240 ASA ASA S3.6 (2010) 2010 American National Standard Specification for Audiometers 本標準已改版，請參考新版本標準。(ASA S3.6-2018) 243 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-01495 ASA ASA S3.22 (2014) 2014 Specification of Hearing Aid Characteristics 本標準已改版，請參考新版本標準。(ASA S3.22-2014 (R2020))

TFDA-01496 IEC IEC 60601-2-66:2015 2015 Medical electrical equipment Part 2-66: Particular

requirements for the basic safety and essential performance of hearing instruments and hearing instrument system

60601-2-66:2019)

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27/158 246 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-01503 ISO ISO 9693-1:2012 2012 Dentistry — Compatibility testing — Part 1: Metal-ceramic systems - First Edition

原採認標準已廢除，請參考取代標準。(ISO 9693:2019) 247 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-01790 ISO ISO 10477:2018 2018 Dentistry -- Polymer-based crown and bridge materials 本標準已改版，請參考新版本標準。(ISO 10477:2020) 248 Dental/ENT 牙科

學/耳鼻喉科學

TFDA-01963 ISO ISO 17730:2014 2014 Dentistry - Fluoride varnishes 本標準已改版，請參考新版本標準。(ISO 17730:2020) 249 General I

(QS/RM) 通用 (品質管理系統/

風險管理)

TFDA-00087 IEC IEC 60812:1985 1985 Analysis technique for system reliability - Procedure for failure modes and effects analysis (FMEA)

本標準已改版，請參考新版本標準。(IEC 60812: 2006 - Ed. 2.0 )

250 General I (QS/RM) 通用 (品質管理系統/

風險管理)

TFDA-00089 ISO ISO 14971:2000 2000 Medical devices - Application of risk management to medical devices

風險管理)

TFDA-00285 ISO ISO 14155-1 2003 Clinical investigation of medical devices for human subjects — Part 1: General requirements

本標準已廢除，請參考新標準。(ISO 14155:2011/CORR 1:2011)

TFDA-00286 ISO ISO 14155-2 2003 Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans

本標準已廢除，請參考新標準。(ISO 14155:2011/CORR 1:2011)

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28/158 (品質管理系統/

風險管理)

performance of medical devices

風險管理)

TFDA-00437 ISO ISO 14971:2000/

Amd 1:2003

2003 Medical devices -- Application of risk management to medical devices

風險管理)

TFDA-00442 CNS CNS15013 2006 用於法規目的之醫療器材品質管理系統要求原採認標準已廢除

風險管理)

TFDA-00695 ISO ISO 14971:2007 2007 Medical devices -- Application of risk management to medical devices

風險管理)

TFDA-00958 AAMI AAMI HE75:2009 2009 Human factors engineering - Design of medical devices 本標準已改版，請參考新版本標準。(AAMI

HE75:2009(R2018))

TFDA-01012 IEC IEC 62366:2007 2007 Medical devices - Application of usability engineering to medical devices

本標準已被廢除，請參考新標準。(IEC 62366-1:2015)

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風險管理)

1

風險管理)

TFDA-01014 ISO ISO 15223-1:2012 2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1:

General requirements - Second Edition

風險管理)

TFDA-01015 ISO ISO/TR 24971:2013 2013 Medical devices — Guidance on the application of ISO 14971

本標準已改版，請參考新版本標準。(ISO/TR 24971:2020)

風險管理)

TFDA-01505 AAMI AAMI TIR69:2017 2017 Risk management of radio-frequency wireless coexistence for medical devices and systems

本標準已改版，請參考新版本標準。(AAMI

TIR69:2017(R2020))

風險管理)

TFDA-01506 CNS CNS 14509-1-6 2015 醫電設備－第 1-6 部：基本安全與必要性能之一般要求

－附屬標準:可用性(Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability)

TFDA-01508 IEC IEC

62366-1:2015/COR1:

2016

2016 Medical devices –Part 1: Application of usability engineering to medical devices

62366-1:2015+AMD1:2020)

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風險管理) 266 General I

(QS/RM) 通用 (品質管理系統/

風險管理)

TFDA-01515 ISO ISO 80369-3:2016 2016 Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications

80369-3:2016/AMD 1:2019)

風險管理)

TFDA-01516 ISO ISO 80369-5:2016 2016 Small-bore connectors for liquids and gases in healthcare applications—Part 5: Connectors for limb cuff inflation applications

80369-5:2016/COR 1:2017)

風險管理)

TFDA-01518 ISO ISO/TS

19218-1/Amd1:2013

2013 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes AMENDMENT 1 - First Edition

風險管理)

TFDA-01797 AAMI AAMI TIR36:2007 2007 Validation of software for regulated processes 本標準已廢除，無取代標準。

270 General Plastic Surgery/General Hospital 一般及

TFDA-00117 ISO ISO 10555-1:1995, A1: 1999

1999 Sterile - Single-use Intravascular catheters Part 1: General requirements

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31/158 271 General Plastic

Surgery/General Hospital 一般及整形外科手術/一般醫院及個人使用裝置

TFDA-00118 ISO ISO 10555-3:1996, Cor1:2002

2002 Sterile Single-Use Intravascular Catheters part 3: Central Venous Catheter

272 General Plastic Surgery/General Hospital 一般及整形外科手術/一般醫院及個人使用裝置

TFDA-00119 ISO ISO 10555-5:1996, A1:1999

2002 Sterile, Single-use Intravascular Catheters - Part 5:

Over-Needle Peripheral Catheters, Amendment 1 1999-06-15

TFDA-00120 ISO ISO 7886-1:1993 1995 Sterile Hypodermic Syringes for Single Use - Part 1:

Syringes for Manual Use

TFDA-00121 ISO ISO 7886-2:1996 1996 Sterile Hypodermic Syringes for Single Use - Part 2:

Syringes for use with Power-Driven Syringe Pumps

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TFDA-00122 ISO ISO 8536-1:2000, A1:2004

2000 Infusion Equipment for Medical Use - Part 1: Infusion Glass Bottles

TFDA-00123 ISO ISO 8536-2:2001, Cor 1:2003

1992 Infusion Equipment for Medical Use - Part 2: Closures for Infusion Bottles

本標準已改版，請參考新版本標準。(ISO 8536-2:2010 )

TFDA-00124 ISO ISO 8536-3:1999 1992 Infusion Equipment for Medical Use - Part 3: Aluminum Caps for Infusion Bottles

TFDA-00125 ISO ISO 8536-4:2004 1998 Infusion Equipment for Medical Use - Part 4: Infusion Sets for Single Use, Gravity Feed

8536-4:2010/Amd 1:2013)

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TFDA-00127 ISO ISO 8536-6:1995 1996 Infusion Equipment for Medical Use - Part 6: Freeze Drying Closures for Infusion Bottles

TFDA-00128 ISO ISO 8536-7:1999 1999 Infusion Equipment, Caps made of Aluminum-Plastic Combinations for Infusion Bottles

TFDA-00287 ISO ISO 595/1 1988 Reusable all-glass or metal-and-glass syringes for medical use - Part 1: Dimensions

TFDA-00288 ISO ISO 595/2 1987 Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests

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TFDA-00289 ISO ISO 7864:1993 1993 Sterile hypodermic needles for single use 本標準已改版，請參考新版本標準。(ISO 7864:2016)

TFDA-00290 IEC IEC 60601-2-19:1996 1996 Amendment 1 - Medical electrical equipment Part 2:

Particular requirements for safety of baby incubators

60601-2-19+A11:2011)

TFDA-00291 IEC IEC 60601-2-2:1998 2000 Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment

本標準已改版，請參考新版本標準。(IEC 60601-2-2 ed5.0 : 2009)

TFDA-00292 ASTM ASTM D5151-99 1999 Standard Test Method for Detection of Holes in Medical Gloves

D5151-06/(R)2011)

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TFDA-00293 ISO ISO 9626:1991 2001 Stainless steel needle tubing for the manufacture of medical devices

TFDA-00294 ASTM ASTM E1112-00 2000 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

E1112-00/(R)2011)

TFDA-00295 ASTM ASTM D6124-01 2001 Standard Test Method for Residual Powder on Medical Gloves

D6124-06/(R)2011)

TFDA-00296 ASTM ASTM D3578-01ae2 2002 Standard Specification for Rubber Examination Gloves 本標準已改版，請參考新版本標準。(ASTM

D3578-05/(R)2010)

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TFDA-00297 ASTM ASTM D3577-01ae2 2002 Standard Specification for Rubber Surgical Gloves 本標準已改版，請參考新版本標準。(ASTM

D3577-09/(E)2009)

TFDA-00299 ASTM ASTM D3772-01 2002 Standard Specification for Natural Rubber Finger Cots 本標準已改版，請參考新版本標準。(ASTM D3772-15)

F882-84(R2002)

1985 Standard Performance and Safety Specification for Cryosurgical Medical Instruments

TFDA-00301 ASTM ASTM F754-00 2000 Standard Specification for Implantable

Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod Shapes

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TFDA-00302 ASTM ASTM F1441-03 2003 Standard Specification for Soft-Tissue Expander Devices 本標準已改版，請參考新版本標準。(ASTM

F1441-03/(R)2009)

TFDA-00303 ISO ISO 11608-1:2000 2000 Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods

TFDA-00304 ISO ISO 11608-2:2000 2000 Pen-injectors for medical use - Part 2: Needles - Requirements and test methods

TFDA-00305 ISO ISO 11608-3:2000 2000 Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods